HEALTHY ACCENTS PAIN RELIEF- acetaminophen capsule, liquid filled

Healthy Accents Pain Relief by

Drug Labeling and Warnings

Healthy Accents Pain Relief by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

• has liver disease
• is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

  These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 capsules every 4 to 6 hours while symptoms last
  • do not take more than 10 capsules in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• children 6-11 years:
  • take 1 capsule every 4 to 6 hours while symptoms last
  • do not take more than 5 capsules in 24 hours
  • do not use for more than 5 days unless directed by a doctor
• children under 6 years:

  ask a doctor

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Tylenol® Liquid Gels active ingredient

regular strength

pain relief

acetaminophen

pain reliever – fever reducer

90 liquid gels**

325mg each

NO GLUTEN

**liquid-filled capsules

INGREDIENTS AND APPEARANCE

HEALTHY ACCENTS PAIN RELIEF 
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-411
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	A325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-411-75	1 in 1 CARTON	05/11/2016
1		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/11/2016

Labeler - DZA Brands LLC (090322194)